UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062476 |
|---|---|
| Receipt number | R000071051 |
| Scientific Title | Immediate Effects of Neuromuscular Electrical Stimulation Applied to the Tibialis Anterior on Muscle Activity and Postural Control in Individuals with a History of Ankle Sprain: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/05 12:55:41 |
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Basic information
Public title
Effects of Electrical Stimulation on Muscle Activity and Dynamic Balance in Individuals with a History of Ankle Sprain
Acronym
Ankle Sprain NMES Study
Scientific Title
Immediate Effects of Neuromuscular Electrical Stimulation Applied to the Tibialis Anterior on Muscle Activity and Postural Control in Individuals with a History of Ankle Sprain: A Randomized Crossover Trial
Scientific Title:Acronym
ANKLE-NMES-XO
Region
| Japan |
Condition
Condition
History of ankle sprain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the immediate effects of neuromuscular electrical stimulation (NMES) applied to the tibialis anterior, compared with sham stimulation, on neuromuscular excitation of the tibialis anterior during muscle contraction and postural control assessed by a clinical balance test in individuals with a history of ankle sprain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tibialis anterior electromyographic amplitude during maximal voluntary isometric contraction, assessed immediately before and immediately after each intervention.
Key secondary outcomes
Star Excursion Balance Test score and lower-limb joint angles during the task, assessed immediately before and immediately after each intervention.
Maximal voluntary ankle dorsiflexion strength, assessed immediately before and immediately after each intervention.
Tibialis anterior electromyographic frequency characteristics (e.g., median frequency) during maximal voluntary isometric contraction, assessed immediately before and immediately after each intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Surface electrodes will be placed over the proximal and distal portions of the tibialis anterior muscle. Neuromuscular electrical stimulation (NMES) will be delivered using a low-frequency electrical stimulation device. Stimulation parameters will be set as follows: biphasic rectangular pulses, frequency of 50 Hz, and pulse duration of 50 us. Stimulation intensity will be adjusted to elicit a muscle contraction corresponding to approximately 20-30% of maximal voluntary isometric contraction, while remaining within a pain-free tolerance level for each participant. The intervention will be applied for 10 minutes using a 5-second on / 15-second off duty cycle (30 cycles in total).
Interventions/Control_2
As a sham condition, transcutaneous electrical nerve stimulation (TENS) will be applied. Electrode placement will be identical to that used in the NMES condition, over the proximal and distal portions of the tibialis anterior muscle. Stimulation will be delivered using biphasic rectangular pulses at a frequency of 100 Hz with a pulse duration of 10 us. The stimulation intensity will be set at a level that elicits a mild sensory perception (tingling sensation) without producing any visible muscle contraction. The stimulation will be applied continuously for 10 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following criteria will be included:
1. Adults aged 18-29 years who can provide written informed consent
2. Engaging in sports activity at least three times per week (sport level not restricted)
3. Having experienced at least one lateral ankle sprain (involving the anterior talofibular, calcaneofibular, or posterior talofibular ligament) within the past 12 months
4. Reporting residual subjective instability in the previously injured ankle
5. Having a history of ankle sprain diagnosed by a physician or confirmed by a physical therapist based on orthopedic clinical tests
6. No musculoskeletal or neurological disorders within the past 6 months other than ankle sprain
Key exclusion criteria
Participants meeting any of the following exclusion criteria will be excluded:
1. History of lower limb surgery or fracture
2. Presence of implanted medical devices such as a pacemaker
3. Pregnancy
4. Malignancy, acute inflammation, or apparent neurological disorder
5. Individuals judged as unsuitable for participation by a physician or physical therapist
6. Acute phase following ankle sprain in which participation in the intervention and measurements may pose a risk to health
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Shojiro |
| Middle name | |
| Last name | NOZU |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8579
Address
6-6-12 Aramaki-aza-Aoba, Aoba-ku, Sendai City, Miyagi, Japan
TEL
022-795-5879
shojiro.nozu.a5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | NOZU |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8579
Address
6-6-12 Aramaki-aza-Aoba, Aoba-ku, Sendai City, Miyagi, Japan
TEL
022-795-5879
Homepage URL
shojiro.nozu.a5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Protection Center
Address
2-1-1 Katahira, Aoba-ku, Sendai City, Miyagi, Japan
Tel
022-217-6184
tuhrp-office@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071051
